Regulatory Affairs Director
2 weeks ago
Dyne Therapeutics Inc is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing our regulatory strategy to ensure compliance with regulatory requirements.
Key Responsibilities:
- Develop and implement regulatory strategies to support clinical development and registration of pharmaceuticals
- Provide global regulatory guidance to program teams on requirements for clinical development and registration
- Oversee preparation, review, and submission of regulatory documents to ensure compliance with regulatory requirements
- Manage timelines and preparation of meeting requests and briefing documents
- Author/edit documents to support regulatory submissions
- Compile, review, and submit clinical trial and marketing registration applications, amendments, and supplements
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports
- Support the organization with health authority meetings
- Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease
- Manage staff and vendors as needed to support regulatory activities
Requirements:
- Minimum of a bachelor's degree in life science or related discipline
- Minimum of 8-10 years of experience in regulatory strategy in a clinical-stage biotechnology company
- Strong experience with CTD format and content regulatory filings
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
- Experience in Health Authority Meetings
- Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus
- Ability to work independently to manage multiple projects in a fast-paced environment
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones
- Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management
- Outstanding communication skills (verbal and written), regulatory writing skills, and willingness to share knowledge and lessons learned
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